Efficacy of Auricular Acupuncture Therapy in the Prevention of CIPN in Breast Cancer

Not Applicable

Recruiting

• Conditions: Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer

• Registration Number: NCT07092111
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

Evaluate the Efficacy of Auricular Acupuncture Therapy via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer

Detailed Description

This is a Phase II Randomised Controlled Clinical Trial to evaluate the efficacy of auricular acupuncture therapy via the Seirin Pyonex Needles in the prevention of chemotherapy-induced peripheral neuropathy in breast cancer.

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-08
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Primary Completion: 2025-09
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Patients with breast cancer diagnosed with stage I-III;
• Planned to receive 4 cycles of taxane chemotherapy and have not taken neurostable drugs within three months;
• 18 years old≤ age≤ 75 years old, female;
• Subjects voluntarily participate in this trial and sign the informed consent form.

Exclusion Criteria

• Patients who have had acupuncture treatment in the past;
• After examination by a doctor, there is a local infection at or near the acupuncture site, which is not suitable for acupuncture.
• Platelets< 50,000/μL;
• Patients with CIPN≥1 grade 1 (NCI-CTCAE);
• Peripheral neuropathy or other neuropathic pain caused by diabetes mellitus or other factors related to HIV infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of CIPN at the end of the 4th chemotherapy	From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)	Incidence of CIPN at the end of the 4th application of taxane chemotherapy (according to NCI-CTCAE V5.0)

Secondary Outcome Measures

Name	Time	Method
Incidence of CIPN at the end of the 3rd chemotherapy	From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)	Incidence of CIPN before the first treatment, at the end of the first three taxane chemotherapy treatments, and at 2 months of follow-up.
CIPN neurotoxicity change	From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)	The FACT/GOG-Ntx scale was used to evaluate the change in CIPN neurotoxicity symptom scores before the first treatment, at the end of the second taxane chemotherapy, at the end of the fourth taxane chemotherapy, and at 2 months of follow-up.
The degree of sensory impairment	From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)	The degree of sensory impairment was assessed by Semmes-Weinstein monofilament tactile test before the first treatment, at the end of the fourth taxane chemotherapy, and at 2 months of follow-up.
The pain intensity score	From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)	The NRS scale assessed the pain intensity score before the first treatment, at the end of the second taxane chemotherapy, at the end of the fourth taxane chemotherapy, and at 2 months of follow-up.
The General Hospital Anxiety/Depression (HAD)	From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)	The General Hospital Anxiety/Depression (HAD) Mood Measurement Form was used to evaluate the physical fitness score of patients before the first treatment and at the end of the fourth taxane chemotherapy.

Trial Locations

Locations (1)

Jiangsu Provincial People's Hospital; 🇨🇳 Nanjing, Jiangsu, China